Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-02-22 @ 7:26 AM
Study NCT ID:
NCT02952703
Status:
COMPLETED
Last Update Posted:
2018-10-12
First Post:
2016-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Disseminating and Implementing a Smoking Cessation Program for Pregnant and Postpartum Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005298', 'term': 'Fertility'}], 'ancestors': [{'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-24', 'size': 999532, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2018-10-09T15:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2016-10-31', 'studyFirstSubmitQcDate': '2016-10-31', 'lastUpdatePostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemically verified smoking abstinence', 'timeFrame': '6 months post intervention', 'description': 'Biochemically verified smoking abstinence: Breath Carbon Monoxide (CO)\\<9ppm'}], 'secondaryOutcomes': [{'measure': 'Motivation to quit/remain quit', 'timeFrame': '6 months post intervention', 'description': 'Motivation to quit/remain quit measured on a 5 point Likert scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Smoking', 'Tobacco Use Disorder']}, 'descriptionModule': {'briefSummary': 'This study tests whether a smoking cessation intervention for pregnant women that extends postpartum (Striving to Quit (STQ)) can be implemented and disseminated outside of the research environment that established its effectiveness (40% maintained biochemically verified 6-month abstinence). The research aim is:\n\nIs Striving to Quit more effective in achieving postpartum smoking cessation than "First Breath," the current standard of care for pregnant women in Wisconsin who smoke?\n\n250 women will be randomized into one of two study groups. Pregnant women in Group A (n=125) will receive the existing First Breath prenatal intervention. Those in Group B (Striving to Quit (STQ), n=125) will receive all Group A interventions, plus 1 additional prenatal home visit, 3 postpartum in-home smoking cessation counseling visits, 3 postpartum phone calls, and up to an additional $100 in gift cards. The primary outcome will be biochemically confirmed smoking cessation at 6-months postpartum.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant;\n* enrolled in First Breath;\n* Resides in Wisconsin counties of Calumet, Fond Du Lac, Kewaunee, Menominee, Oconto, Shawno, Sheyboygan, Winnebago, Door, Brown, Outagamie, Manitowac, or Waupaca;\n* English speaking;\n* willingness to quit or reduce smoking in next 30 days or if already quit, desire to remain quit after delivery;\n* daily smoking (at least 1 cigarette/day for at least 1 week in past 6 months;\n* willing to provide updates in contact information\n\nExclusion Criteria:\n\n* not pregnant;\n* not smoking in past 6 months;\n* involved in another smoking research study.'}, 'identificationModule': {'nctId': 'NCT02952703', 'briefTitle': 'Disseminating and Implementing a Smoking Cessation Program for Pregnant and Postpartum Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Disseminating and Implementing a Smoking Cessation Program Fro Pregnant and Postpartum Women', 'orgStudyIdInfo': {'id': '2016-1046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'First Breath', 'description': 'brief pre-natal smoking cessation counseling', 'interventionNames': ['Behavioral: brief pre-delivery smoking cessation counseling']}, {'type': 'EXPERIMENTAL', 'label': 'Striving to Quit', 'description': 'Additional pre-natal counseling (in-person and telephonic); post delivery counseling (in-person and telephonic) and incentives', 'interventionNames': ['Behavioral: additional pre-delivery smoking cessation counseling', 'Behavioral: post- delivery smoking cessation counseling', 'Behavioral: incentives']}], 'interventions': [{'name': 'brief pre-delivery smoking cessation counseling', 'type': 'BEHAVIORAL', 'armGroupLabels': ['First Breath']}, {'name': 'additional pre-delivery smoking cessation counseling', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Striving to Quit']}, {'name': 'post- delivery smoking cessation counseling', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Striving to Quit']}, {'name': 'incentives', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Striving to Quit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53711', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}